Annatto-derived GG for Statin-associated Myopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Low GG, High GG.
- Who it may be relevant to
- Registry conditions: Myopathy; Primary. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Annatto-derived Geranylgeraniol (GG) on Statin-associated Myopathy
Overview
To evaluate the effects of 3-months annatto-derived geranylgeraniol (GG) supplementation on statin-associated skeletal muscle health.
Detailed description
Statins are widely prescribed cholesterol-lowering oral drugs. The majority of reported adverse effects due to statin include muscle pain, weakness, cramp, and tiredness. CoQ10 supplementation has been widely used to reduce statin-related muscle complaints. Several human studies have been reported with inconsistent effects of CoQ10 on statin-related symptoms. This study is to investigate the role of 3-month annatto-derived geranylgeraniol (GG) in statin-related muscle outcomes in humans. Qualified subjects will be matched by age, gender, and body weight, and then randomly assigned to a no GG group, a low GG dose group, or a high GG dose group. The outcome measures will be assessed at baseline and after 3 months. Muscle-associated measurements will be recorded using subject questionnaires (also follow-up after 3 and 6 months), muscle performance results, and blood samples. We will monitor the safety of subjects after 3 months. Food intake, physical activity, and medication changes will be recorded at baseline and after 3 months. All data will be analyzed statistically.
Interventions
- Dietary supplement Placebo
300 mg olive oil - Dietary supplement Low GG
150 mg GG - Dietary supplement High GG
300 mg GG
Primary outcome measures
- SAMS-CI [Time frame: change in SAMS-CI at 3 months]
- BPI [Time frame: change in BPI at 3 months]
Secondary outcome measures (11)
- Lower body isometric strength [Time frame: change in lower body isometric strength at 3 months]
- Functional lower body strength [Time frame: change in functional lower body strength at 3 months]
- Wall-sit test [Time frame: change in wall-sit test at 3 months]
- Heel raise test [Time frame: change in heel raise test at 3 months]
- blood biomarkers: serum creatinine kinase activity [Time frame: change in serum creatinine kinase activity at 3 months]
- blood biomarkers: myostatin [Time frame: changes in serum myostatin at 3 months]
- blood biomarkers: atrogin 1 [Time frame: changes in serum atrogin 1 at 3 months]
- blood biomarkers: hsCRP [Time frame: changes in serum hsCRP at 3 months]
- blood biomarker: IL-6 [Time frame: changes in serum IL-6 at 3 months]
- blood lipid profiles [Time frame: changes in blood lipid profiles at 3 months]
- plasma menaquinone-4 (MK4) + menaquinone-4 (MK7) [Time frame: changes in plasma MK4+MK7 at 3 months]
Eligibility criteria
Inclusion criteria
- Age ≥40 of either sex
- Statin-treated patients with muscle pain alone or accompanied by other symptoms.
- Patients currently receiving a statin who developed new-onset myalgias in within 90 day of initiation or a dosage increase
Exclusion criteria
- Malignancy or significant neurological or psychiatric disturbances, including alcohol or drug abuse.
- Woman who is pregnant, breastfeeding, or of childbearing potential and not taking adequate contraceptive precautions.
- Had CoQ10 supplement one month before starting the study.
- Genetic musculoskeletal and neurologic disorder known to affect skeletal muscle metabolism
- Had steroid medication one month before starting the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Texas Tech University Health Sciences Center — Lubbock
Identifiers
NCT: NCT05312424 · L22-130